The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

Symptomatic Hip Osteoarthritis Clinical Trial

Official title: Multicentre, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis

Status Terminated

Clinical Trial Summary

To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip.

Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic hip and will be followed up for three months.

At the third month, if the score for overall pain is still > 40 mm on the VAS, a second injection of ADANT® can be given irrespective of which treatment was received previously. The patient will be followed up for a further 3 months in an open-label fashion (monthly visits).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Symptomatic Hip Osteoarthritis

• NCT number: NCT00330135
• Study type: Interventional
• Source: Daiichi Sankyo Inc.
• Status: Terminated
• Phase: Phase 3
• Start date: January 2005
• Completion date: March 2007